We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines. This bulletin covers five key FDA actions from March 2026.
Pylarify TruVu — Prostate Cancer Imaging
The FDA approved Pylarify TruVu, a new formulation of the prostate cancer imaging agent piflufolastat F 18, on March 6, 2026. The updated formulation offers a higher-concentration, stable formulation designed to improve manufacturing efficiency and distribution reliability. Commercial launch is anticipated in Q4 2026.
Sotyktu — Expanded to Psoriatic Arthritis
Bristol Myers Squibb's oral TYK2 inhibitor Sotyktu (deucravacitinib) received FDA approval on March 6, 2026 for the treatment of active psoriatic arthritis in adults. Clinical trial data showed 54% of patients treated with Sotyktu achieved an ACR 20 response at week 16, compared with 34%–39% in those treated with placebo. The drug was previously approved for moderate-to-severe plaque psoriasis.
Leucovorin Calcium — Cerebral Folate Transport Deficiency
On March 10, 2026, the FDA approved leucovorin calcium oral solution as the first approved treatment for cerebral folate transport deficiency (CFTD), a rare genetic disorder that impairs folate delivery to the brain. Recommended dosing begins at 1–2 mg/kg/day and may be adjusted to a maximum of 8.5 mg/kg/day for patients weighing under 40 kg, or 330 mg/day for those 40 kg or more.
Tazverik — Market Withdrawal
Ipsen voluntarily withdrew Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor, from the U.S. market on March 9, 2026. The withdrawal follows an identified imbalance in hematologic secondary malignancies, including cases suggestive of myelodysplastic syndrome (MDS) and acute leukemia, observed in post-market surveillance. Healthcare organizations should review any active prescriptions and update formulary records accordingly.
Arexvy RSV Vaccine — Younger At-Risk Adults
GSK's RSV vaccine Arexvy received FDA approval on March 13, 2026 for immunization of adults aged 18–59 years who are at increased risk of severe RSV infection. The previous approval covered adults 60 and older. GSK estimates that 21 million adults under 50 years of age have at least one risk factor for severe RSV infection, significantly broadening the eligible population for vaccination programs.
This bulletin is provided by VativoRx for informational purposes only and does not constitute clinical, legal, or financial advice. Drug approvals, indications, and market status are subject to change. Readers should consult prescribing information and applicable regulatory guidance for current details.